Tactile Medical Receives PDAC Approval for Nimbl™ Lymphedema Platform
Tactile Medical (Nasdaq: TCMD) has received PDAC approval for its Nimbl™ Lymphedema Platform, allowing Medicare billing under HCPCS code E0651. This approval follows the FDA's 510(k) clearance in June 2024. Nimbl, the next-generation pneumatic compression device for lymphedema treatment, offers significant improvements:
- 40% size reduction and 68% weight reduction, enhancing portability
- Integration with the Kylee™ digital app for therapy tracking
- Indicated for lymphedema, chronic edema, venous insufficiency, and wound healing
CEO Sheri Dodd emphasized Nimbl's potential to improve patient acceptance and adherence. The device is set for full commercial launch in the coming weeks, reflecting Tactile Medical's commitment to innovative at-home therapies for chronic conditions.
Tactile Medical (Nasdaq: TCMD) ha ricevuto l'approvazione PDAC per la sua Piattaforma Nimbl™ per Linfedema, consentendo la fatturazione Medicare sotto il codice HCPCS E0651. Questa approvazione segue l'autorizzazione 510(k) della FDA avvenuta a giugno 2024. Nimbl, il dispositivo per compressione pneumatica di nuova generazione per il trattamento del linfedema, offre miglioramenti significativi:
- riduzione delle dimensioni del 40% e del peso del 68%, aumentando la portabilità
- Integrazione con l'app digitale Kylee™ per il monitoraggio della terapia
- Indicato per linfedema, edema cronico, insufficienza venosa e guarigione delle ferite
Il CEO Sheri Dodd ha sottolineato il potenziale di Nimbl nel migliorare l'accettazione e l'aderenza dei pazienti. Il dispositivo è destinato a un lancio commerciale completo nelle prossime settimane, riflettendo l'impegno di Tactile Medical verso terapie innovative a domicilio per condizioni croniche.
Tactile Medical (Nasdaq: TCMD) ha recibido la aprobación PDAC para su Plataforma Nimbl™ para Linfedema, permitiendo la facturación de Medicare bajo el código HCPCS E0651. Esta aprobación sigue a la autorización 510(k) de la FDA en junio de 2024. Nimbl, el dispositivo de compresión neumática de nueva generación para el tratamiento del linfedema, ofrece mejoras significativas:
- reducción del tamaño del 40% y del peso del 68%, mejorando la portabilidad
- Integración con la aplicación digital Kylee™ para el seguimiento de la terapia
- Indicado para linfedema, edema crónico, insuficiencia venosa y curación de heridas
La CEO Sheri Dodd enfatizó el potencial de Nimbl para mejorar la aceptación y la adherencia de los pacientes. El dispositivo está programado para un lanzamiento comercial completo en las próximas semanas, reflejando el compromiso de Tactile Medical con terapias innovadoras en casa para condiciones crónicas.
텍타일 메디컬(Tactile Medical) (Nasdaq: TCMD)은 닌블(Nimbl™ 림프부종 플랫폼)에 대한 PDAC 승인을 받았으며, HCPCS 코드 E0651로 메디케어 청구를 허용합니다. 이 승인은 2024년 6월 FDA의 510(k) 승인을 따른 것입니다. 닌블은 림프부종 치료를 위한 차세대 공기 압축 장치로, 다음과 같은 유의미한 개선 사항을 제공합니다:
- 40% 크기 감소 및 68% 무게 감소, 휴대성 향상
- 치료 추적을 위한 카일리(Kylee™) 디지털 앱과의 통합
- 림프부종, 만성 부종, 정맥 부족 및 상처 치유에 적합
CEO 셰리 도드(Sheri Dodd)는 닌블이 환자의 수용성과 준수를 개선할 수 있는 잠재력을 강조했습니다. 이 장치는 Tactile Medical이 만성 질환을 위한 혁신적인 홈 치료에 대한 약속을 반영하며, 곧 상업적 출시를 앞두고 있습니다.
Tactile Medical (Nasdaq: TCMD) a obtenu l'approbation PDAC pour sa Plateforme Nimbl™ pour Lymphœdème, permettant la facturation Medicare sous le code HCPCS E0651. Cette approbation fait suite à l'autorisation 510(k) de la FDA en juin 2024. Nimbl, le dispositif de compression pneumatique de nouvelle génération pour le traitement du lymphœdème, offre des améliorations significatives :
- réduction de taille de 40 % et réduction de poids de 68 %, améliorant la portabilité
- Intégration avec l'application numérique Kylee™ pour le suivi de la thérapie
- Indiqué pour le lymphœdème, l'œdème chronique, l'insuffisance veineuse et la cicatrisation des plaies
La PDG Sheri Dodd a souligné le potentiel de Nimbl pour améliorer l'acceptation et l'adhérence des patients. L'appareil est prêt pour un lancement commercial complet dans les semaines à venir, reflétant l'engagement de Tactile Medical envers des thérapies à domicile innovantes pour les maladies chroniques.
Tactile Medical (Nasdaq: TCMD) hat die PDAC-Zulassung für seine Nimbl™ Lymphödem-Plattform erhalten, die die Abrechnung von Medicare unter dem HCPCS-Code E0651 ermöglicht. Diese Genehmigung folgt auf die 510(k)-Zulassung der FDA im Juni 2024. Nimbl, das nächste Generation Pneumatik-Kompressionsgerät zur Behandlung von Lymphödemen, bietet wesentliche Verbesserungen:
- 40% Größenreduktion und 68% Gewichtsreduktion, was die Tragbarkeit verbessert
- Integration mit der Kylee™-Digital-App zur Therapieverfolgung
- Geeignet für Lymphödeme, chronische Ödeme, venöse Insuffizienz und Wundheilung
CEO Sheri Dodd betonte das Potenzial von Nimbl, die Akzeptanz und die Compliance der Patienten zu verbessern. Das Gerät wird in den kommenden Wochen vollständig kommerziell eingeführt und spiegelt das Engagement von Tactile Medical für innovative Therapien zu Hause bei chronischen Erkrankungen wider.
- Received PDAC approval for Nimbl™ Lymphedema Platform, enabling Medicare billing
- Nimbl offers 40% size reduction and 68% weight reduction compared to previous generations
- Integration with Kylee™ digital app for improved therapy tracking and sharing
- Expanded indications including lymphedema, chronic edema, venous insufficiency, and wound healing
- Full commercial launch expected in the coming weeks
- None.
Insights
The PDAC approval for Tactile Medical's Nimbl™ Lymphedema Platform is a significant milestone for the company. This approval, coupled with the earlier FDA clearance, paves the way for Medicare reimbursement, potentially expanding the device's market reach. The Nimbl's 40% size reduction and 68% weight reduction address key patient concerns, potentially improving adoption and adherence rates.
The integration with the Kylee™ digital app adds a telemedicine component, aligning with the growing trend of remote patient monitoring. This feature could be a differentiator in the competitive medical device market. However, the true impact on revenue and market share will depend on the pricing strategy and how effectively Tactile Medical can market these improvements to both healthcare providers and patients.
The Nimbl™ platform represents a significant technological advancement in lymphedema treatment. The device's reduced size and weight, coupled with digital connectivity, address the growing demand for portable and smart medical devices. This aligns with the broader trend of patient-centric care and could potentially improve treatment adherence.
The Kylee™ app integration is particularly noteworthy, as it enables data-driven care. By allowing patients to track and share their progress, it could lead to more personalized treatment plans and better outcomes. However, the success of this feature will depend on its user-friendliness and the willingness of healthcare providers to incorporate this data into their decision-making processes.
The PDAC approval for Nimbl™ using HCPCS code E0651 is a crucial regulatory win for Tactile Medical. This approval streamlines the reimbursement process for Medicare patients, potentially expanding the addressable market. The timing of this approval, coming earlier than expected, could give Tactile Medical a competitive advantage in the lymphedema treatment space.
However, investors should note that while PDAC approval is important, it doesn't guarantee widespread adoption. The company will need to demonstrate the device's cost-effectiveness and clinical benefits to ensure favorable coverage decisions from private insurers and to encourage healthcare providers to prescribe the device. The success of Nimbl™ will ultimately depend on its ability to improve patient outcomes and reduce overall healthcare costs.
Next-Generation System Significantly Reduces Device Size and Weight and Enables Integration with Kylee™ Digital App
MINNEAPOLIS, Sept. 16, 2024 (GLOBE NEWSWIRE) -- Tactile Systems Technology, Inc. (“Tactile Medical”; the “Company”) (Nasdaq: TCMD), a medical technology company providing therapies for people with chronic disorders, today announced that the Pricing, Data Analysis, and Coding (PDAC) contractor for the Centers for Medicare & Medicaid Services (CMS) has approved the use of Healthcare Common Procedure Coding System (HCPCS) code E0651 for billing the Durable Medical Equipment Medicare Administrative Contractors for Nimbl™, the Company’s next-generation pneumatic compression platform. PDAC approval is subsequent to the receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) in June 2024. The Company will make Nimbl commercially available in the United States in the coming weeks.
Nimbl is the next generation of the Company’s basic lymphedema compression solution and is indicated for the treatment of lymphedema, chronic edema, venous insufficiency, and wound healing. The device features several key patient-friendly enhancements over prior generations, including a
“The receipt of PDAC approval for Nimbl comes earlier than expected, and we are pleased that CMS recognizes the potential health and quality-of-life enhancing benefits this device offers for Medicare patients struggling with lymphedema and chronic venous insufficiency,” said Sheri Dodd, Chief Executive Officer at Tactile Medical. “Nimbl’s new sleeker design and technical advancements reflect our commitment to meaningful product innovation that seeks to meet the patient wherever they are in the treatment pathway. I am proud of the work our team has accomplished in developing this new platform, which I believe will elevate lymphedema therapy and increase patient acceptance and adherence. We look forward to Nimbl’s upcoming full commercial launch in the weeks ahead.”
About Tactile Systems Technology, Inc. (DBA Tactile Medical)
Tactile Medical is a leader in developing and marketing at-home therapies for people suffering from underserved, chronic conditions including lymphedema, lipedema, chronic venous insufficiency and chronic pulmonary disease by helping them live better and care for themselves at home. Tactile Medical collaborates with clinicians to expand clinical evidence, raise awareness, increase access to care, reduce overall healthcare costs and improve the quality of life for tens of thousands of patients each year.
Investor Inquiries:
Sam Bentzinger
Gilmartin Group
investorrelations@tactilemedical.com
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